Neonatal Respiratory Distress SyndromeNCT03446937
Effect of Antenatal Corticosteroids on Neonatal Morbidity.
A study testing Dexamethasone Sodium Phosphate Injection, Betamethasone Sodium Phosphate Injection (Medication) and Water for injection in people with Neonatal Respiratory Distress Syndrome, run by Ahmadu Bello University Teaching Hospital at 1 site in Nigeria.
Trial summary
It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Respiratory Distress Syndrome
- What is being tested?
- Dexamethasone Sodium Phosphate Injection, Betamethasone Sodium Phosphate Injection (Medication) and Water for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Dec 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation and a probability of delivery in the late preterm period irrespective of diagnosis who give consent.
- Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation scheduled for elective/emergency delivery in the late preterm period irrespective of indication and route of delivery who give consent.
Who cannot join
- Evidence of Chrioamnionitis.
- Evidence of foetal distress.
- History of use of antenatal corticosteroids in index pregnancy.
- Women who do not give consent.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Ahmadu Bello University Teaching Hospital Shika-Zaria
Zaria, Kaduna State, PMB 06
About this study
It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo.
Read the detailed description
The study will be a double blind randomised controlled trial. There will be two study groups and one control group.
The first study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular dexamethasone sodium phosphate.
The second study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular betamethasone sodium phosphate.
The control group will be pregnant women at risk of late preterm birth that will be given intramuscular water for injection.
- Conditions
- Neonatal Respiratory Distress Syndrome
- Being tested
- Dexamethasone Sodium Phosphate Injection, Betamethasone Sodium Phosphate Injection (Medication), Water for injection
- Keywords
- Antenal corticosteroids, Late preterm delivery, Neonatal morbidity
- Medical subject headings
- Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Sodium Phosphate InjectionDrug
Also called Pemadex
Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart
Betamethasone Sodium Phosphate Injection (Medication)Drug
betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart
Water for injectionDrug
Also called Juhel water for injection
Two doses of intramuscular injection of water for injection given 12 hours apart
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone sodium phosphate injection | Experimental | Intervention: Drug: Dexamethasone sodium phosphate injection Two doses Intramuscular Dexamethasone sodium phosphate 12mg given12 hours apart. (produced by Taizhou Overseas International Ltd. 126-128 Qingnian Road Jiaojiang, Taizhou, Zhejiang, China) Receives: Drug: Dexamethasone Sodium Phosphate Injection |
| Betamethasone sodium phosphate injection | Experimental | Intervention: Drug: Betamethasone sodium phosphate injection Two doses of intramuscular betamethasone sodium phosphate 12mg given 12 hours apart. (obtained from Twinbrook pkwy, Rockville, MD Singapore. CAT No 1068004, Lot: R004e0) Receives: Drug: Betamethasone Sodium Phosphate Injection (Medication) |
| Water for injection | Placebo comparator | Intervention. Drug: Water for injection. Two doses of intramuscular water for injection given 12 hours apart. Receives: Drug: Water for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Respiratory distress syndrome
Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement.
Measured: Within the first 72 hours of life
Secondary outcomes (3)
Transient tachypnoea of the newborn:
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
Measured: Within the first 72 hours after delivery/birth
Admission into neonatal intensive care unit.
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
Measured: Within the first 72 hours after delivery/birth
2. Admission into neonatal intensive care unit. Apnoea.
As determined by local treatment protocols at Ahmadu Bello University Teaching Hospital
Measured: Within the first 72 hours after delivery/birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Dec 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmadu Bello University Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anisah Yahya, Ahmadu Bello University Teaching Hospital
- Investigators
- Anisah Yahya, MBBS, Principal investigator, Ahmadu Bello University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446937
- Sponsor's protocol ID
- AhmaduBUTH
- Status last verified
- Dec 2019
- First submitted
- 5 Feb 2018
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The outcome will be shared
Publications
Yahya A, Sulayman HU, Abdulkadir I, Lawal BB. Effect of Antenatal Corticosteroids in Late Preterm Delivery on Neonatal Respiratory Morbidity: A Randomized Controlled Trial. Niger Med J. 2023 Oct 21;64(4):532-544. doi: 10.60787/NMJ-64-4-297. eCollection 2023 Jul-Aug.
PubMed 38952884
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antenatal Corticosteroids on Neonatal Morbidity.
- ClinicalTrials.gov ID
- NCT03446937
- Acronym / sponsor ID
- AhmaduBUTH
- Conditions
- Neonatal Respiratory Distress Syndrome
- Keywords
- Antenal corticosteroids, Late preterm delivery, Neonatal morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ahmadu Bello University Teaching HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo.
Detailed description
The study will be a double blind randomised controlled trial. There will be two study groups and one control group.
The first study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular dexamethasone sodium phosphate.
The second study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular betamethasone sodium phosphate.
The control group will be pregnant women at risk of late preterm birth that will be given intramuscular water for injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone sodium phosphate injection | Experimental | Drug: Dexamethasone Sodium Phosphate InjectionIntervention: Drug: Dexamethasone sodium phosphate injection Two doses Intramuscular Dexamethasone sodium phosphate 12mg given12 hours apart. (produced by Taizhou Overseas International Ltd. 126-128 Qingnian Road Jiaojiang, Taizhou, Zhejiang, China) |
| Betamethasone sodium phosphate injection | Experimental | Drug: Betamethasone Sodium Phosphate Injection (Medication)Intervention: Drug: Betamethasone sodium phosphate injection Two doses of intramuscular betamethasone sodium phosphate 12mg given 12 hours apart. (obtained from Twinbrook pkwy, Rockville, MD Singapore. CAT No 1068004, Lot: R004e0) |
| Water for injection | Placebo comparator | Drug: Water for injectionIntervention. Drug: Water for injection. Two doses of intramuscular water for injection given 12 hours apart. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation and a probability of delivery in the late preterm period irrespective of diagnosis who give consent.
- Pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation scheduled for elective/emergency delivery in the late preterm period irrespective of indication and route of delivery who give consent.
Key exclusion criteria (4 listed)
- Evidence of Chrioamnionitis.
- Evidence of foetal distress.
- History of use of antenatal corticosteroids in index pregnancy.
- Women who do not give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Sodium Phosphate InjectionAlso: PemadexDexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart | Drug | Dexamethasone sodium phosphate injection |
| Betamethasone Sodium Phosphate Injection (Medication)betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart | Drug | Betamethasone sodium phosphate injection |
| Water for injectionAlso: Juhel water for injectionTwo doses of intramuscular injection of water for injection given 12 hours apart | Drug | Water for injection |
Primary outcome
Neonatal Respiratory distress syndrome
Time frame: Within the first 72 hours of life
Tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray and oxygen requirement.
3 secondary outcomes
Transient tachypnoea of the newborn:
Time frame: Within the first 72 hours after delivery/birth
Admission into neonatal intensive care unit.
Time frame: Within the first 72 hours after delivery/birth
2. Admission into neonatal intensive care unit. Apnoea.
Time frame: Within the first 72 hours after delivery/birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Derived from this study: PubMed 38952884Yahya A, Sulayman HU, Abdulkadir I, Lawal BB. Effect of Antenatal Corticosteroids in Late Preterm Delivery on Neonatal Respiratory Morbidity: A Randomized Controlled Trial. Niger Med J. 2023 Oct 21;64(4):532-544. doi: 10.60787/NMJ-64-4-297. eCollection 2023 Jul-Aug.
- Individual participant dataSharing planned: Yes. The outcome will be shared
Related trials for Neonatal Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anisah Yahya, MBBS principal investigator
Ahmadu Bello University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone Sodium Phosphate Injection, Betamethasone Sodium Phosphate Injection (Medication) and Water for injection in people with Neonatal Respiratory Distress Syndrome, run by Ahmadu Bello University Teaching Hospital at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Respiratory distress syndrome (time frame: Within the first 72 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.